Medical devices; reports of corrections and removals; lift of stay of effective date--FDA. Final rule; lift of stay of effective date

The Food and Drug Administration (FDA) is lifting a stay of the effective date of certain provisions in a final rule on establishing procedures for submission of reports of corrections and removals of medical devices. The Office of Management and Budget (OMB) has approved the collection of information requirements contained in the final rule.     

Revision of the requirements for live vaccine processing; confirmation of effective date. Direct final rule; confirmation of effective date

The Food and Drug Administration (FDA) is confirming the effective date of March 18, 2008, for the direct final rule that appeared in the Federal Register of October 18, 2007 (72 FR 59000). The direct final rule amends the biologics regulations by providing options to the existing requirements for the processing of live vaccines. This document confirms the effective date of the direct final rule.     

Conforming regulations regarding removal of section 507 of the Federal Food, Drug, and Cosmetic Act; confirmation of effective date. Food and Drug Administration, HHS. Direct final rule; confirmation of effective date

The Food and Drug Administration (FDA) published in the Federal Register of January 5, 1999 (64 FR 396), a direct final rule. The direct final rule amended FDA's regulations by removing references to the repealed statutory provision of the Federal Food, Drug, and Cosmetic Act (the act) under which the agency certified antibiotic drugs. The direct final rule also removed references to the repealed antibiotic monograph regulations and to those regulations dealing with antibiotic applications. This document confirms the effective date of the direct final rule.     

Revisions to the requirements applicable to blood, blood components and source plasma; confirmation of effective date and technical amendment. Direct final rule; confirmation of effective date and technical amendment

The Food and Drug Administration (FDA) is confirming the effective date of February 19, 2008, for the direct final rule that appeared in the Federal Register of August 16, 2007 (72 FR 45883). The direct final rule amends the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. In addition, FDA is making technical amendments to the biologics regulations in response to comments received on the direct final rule.     

Medicaid program; eligibility and coverage requirements--HCFA. Notice of delay of effective dates and compliance dates

This document delays by an additional 6 months the effective dates of the final rule with comment period on Medicaid Eligibility and Coverage Requirements published January 19, 1993, in the Federal Register (58 FR 4908). It also extends the compliance dates for this rule in light of the delay in the effective dates. This delay will give the administration additional time necessary to fully review the policies in these regulations.     

Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document #1; availability. Food and Drug Administration, HHS. Notice

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document #1." The final regulations implementing the Mammography Quality Standards Act of 1992 (the MQSA) will become effective April 28, 1999, and will replace the interim regulations which, under the MQSA, currently regulate mammography facilities. The guidance is intended to assist facilities and their personnel to meet the MQSA final regulations.     

Currently effective Indian Health Service eligibility regulations. Indian Health Service, HHS. Republication of currently effective Indian Health Service eligibility regulations

The HHS is publishing in the Federal Register, final regulations governing eligibility for services from the Indian Health Service. The eligibility regulations currently codified at 42 CFR part 36 are under a congressional moratorium. Republishing the regulations that are currently in effect while the codified regulations are under moratorium is being done for the convenience of the public and in conformance with the requirement of the Administrative Procedure Act, 5 U.S.C. 552(a)(1), that the Code of Federal Regulations (CFR) must contain currently effective regulations.     

Medical devices; device tracking--FDA. Final rule; suspension of effective date; notification of status under the Safe Medical Devices Act; technical amendments

The Food and Drug Administration (FDA) is announcing that it is suspending the effective date of the final rule on device tracking that appeared in the Federal Register of May 29, 1992, until August 29, 1993. The agency is also announcing that the revised proposed rule is now a final rule by operation of law. Further, the agency is amending the regulations to make certain technical amendments. This action is being taken to implement requirements of the Safe Medical Devices Act of 1990 (the SMDA) and the Medical Device Amendments of 1992 (the 1992 amendments).     

Medical devices; medical device distributor reporting--FDA. Final rule; notification of status under the Safe Medical Devices Act; confirmation of effective date

The Food and Drug Administration (FDA) is announcing that the tentative final rule on medical device distributor reporting that appeared in the Federal Register of November 26, 1991 (56 FR 60024), is now a final rule by operation of law. This final rule requires distributors to submit reports to FDA and to manufacturers, of deaths, serious illnesses, and serious injuries related to medical devices and to submit reports to manufacturers of certain malfunctions that may cause a death, serious illness, or serious injury, if the malfunction were to recur. The final rule also changes the reporting standard for certain distributors that are importers, and changes the definition of the term "serious injury" to conform to a recent statutory amendment. In issuing this final rule, FDA is announcing that the tentative final rule relating to adverse event reporting requirements for distributors, including importers, has the status of a final rule, as of May 28, 1992, by operation of law under the Safe Medical Devices Act of 1990 (the SMDA), as amended by the Medical Device Amendments of 1992 (the 1992 amendments), and is setting forth the regulations reflecting those requirements. FDA is also amending the regulations, based on consideration of comments on the November 26, 1991, tentative final rule, to require distributors to register their facilities and to list their devices with FDA.     

Human cells, tissues, and cellular and tissue-based products; establishment registration and listing. Interim final rule; opportunity for public comment

The Food and Drug Administration (FDA) is issuing an interim final rule to except human dura mater and human heart valve allografts, currently subject to application or notification requirements under the Federal Food, Drug, and Cosmetic Act (the act), from the scope of the definition of "human cells, tissues, or cellular or tissue-based products (HCT/P's)" subject to the registration and listing requirements contained in 21 CFR part 1271. That definition became effective on January 21, 2004. FDA is taking this action to assure that these products, which are currently subject to the act and therefore regulated under the current good manufacturing practice regulations set out in the quality system regulations in 21 CFR part 820 are not released from the scope of those regulations before a more comprehensive regulatory framework applicable to HCT/P's, including donor suitability requirements, good tissue practice regulations, and appropriate enforcement provisions, is fully in place. When that comprehensive framework is in place, FDA intends that human dura mater and human heart valves will be subject to it. FDA intends to revoke this interim final rule at that time.     

Use of ozone-depleting substances; removal of essential use designations; confirmation of effective date. Direct final rule; confirmation of effective date

The Food and Drug Administration (FDA) is confirming the effective date of April 23, 2007, for the direct final rule that appeared in the Federal Register of December 7, 2006 (71 FR 70870). The direct final rule amends the regulation to remove beclomethasone, dexamethasone, fluticasone, bitolterol, salmeterol, ergotamine tartrate, and ipratropium bromide, used in oral pressurized metered-dose inhalers, from the list of essential uses of ozone-depleting substances. None of these products is currently being marketed. This document confirms the effective date of the direct final rule.     

Updating OSHA standards based on national consensus standards. final rule; confirmation of effective date

OSHA is confirming the effective date of its direct final rule that revises a number of standards for general industry that refer to national consensus standards. The direct final rule states that it would become effective on March 13, 2008 unless OSHA receives significant adverse comment on these revisions by January 14, 2008. OSHA received no adverse comments by that date and, therefore, is confirming that the rule will become effective on March 13, 2008.     

Public Health Service--health systems agencies and state health planning and development agencies; certificate of need reviews. Notice regarding certificate of need programs

This Notice sets forth advance information regarding amendments to the regulations governing certificate of need reviews by health systems agencies and State health planning and development agencies. This Notice is intended to provide early guidance to States prior to publication of interim final regulations implementing the amendments to certificate of need provisions of the Public Health Service Act made by the Health Planning and Resources Development Amendments of 1979 (Pub. L 96-79). This early guidance will assist the States in beginning to revise their certificate of need laws. Under the amended provisions of the Public Health Service Act, the planning agencies are required to review and determine the need for proposed capital expenditures, institutional health services and major medical equipment. The Secretary intends to publish these interim final regulations within a few weeks. Following consideration of comments which will be solicited with regard to the interim regulations, the Secretary will publish an analysis of the comments and will revise those regulations as appropriate.     

Medicaid program; Medicaid managed care. Withdrawal of final rule with comment period

This document withdraws all provisions of the final rule with comment period on Medicaid managed care that we published in the Federal Register on January 19, 2001 (66 FR 6228) with an initial effective date of April 19, 2001. This January 19, 2001 final rule, which has never taken effect, would have combined Medicaid managed care regulations in a new part 438, implemented Medicaid managed care requirements of the Balanced Budget Act of 1997 (Pub. L. 105-33), and imposed new requirements on entities currently regulated as "prepaid health plans' (PHPs). The regulations set forth in the final rule being withdrawn have been superseded by regulations promulgated in a subsequent rulemaking initiated on August 20, 2001 (66 FR 43613). In addition, this document addresses comments received in response to an interim final rule with comment period that we published on August 17, 2001 in the Federal Register (66 FR 43090) that further delayed, until August 16, 2002, the effective date of the January 19, 2001 final rule with comment period.     

Medicare program; electronic submission of cost reports: revision to effective date of cost reporting period. Interim final rule with comment period

This interim final rule with comment period revises the existing effective date by which all organ procurement organizations (OPOs), rural health clinics (RHCs), Federally qualified health centers (FQHCs), and community mental health centers (CMHCs) are required to submit their Medicare cost reports in a standardized electronic format from cost reporting periods ending on or after December 31, 2004 to cost reporting periods ending on or after March 31, 2005. This interim final rule with comment does not affect the current cost reporting requirement for hospices and end-stage renal disease (ESRD) facilities. Hospices and ESRD facilities are required to continue to submit cost reports under the Medicare regulations in a standardized electronic format for cost reporting periods ending on or after December 31, 2004.     

Medicaid program; payment adjustment for provider-preventable conditions including health care-acquired conditions. Final rule

This final rule will implement section 2702 of the Patient Protection and Affordable Care Act which directs the Secretary of Health and Human Services to issue Medicaid regulations effective as of July 1, 2011 prohibiting Federal payments to States under section 1903 of the Social Security Act for any amounts expended for providing medical assistance for health care-acquired conditions specified in the regulation. It will also authorize States to identify other provider-preventable conditions for which Medicaid payment will be prohibited.     

Medicare program; continuation of Medicare entitlement when disability benefit entitlement ends because of substantial gainful activity. Final rule

This final rule will conform the existing Medicare eligibility regulations to reflect a change made by the Ticket to Work and Work Incentives Improvement Act (TWWIIA) of 1999. That statutory change that was implemented effective October 1, 2000, provides working disabled individuals with continued Medicare entitlement for an additional 54 months beyond the previous limit of 24 months, for a total of 78 months of Medicare coverage following the 15th month of the reentitlement period.